RecruitingACTRN12616000150448

The Persistent Pelvic Pain (PPP) Study: Factors influencing the outcomes in women presenting with persistent pelvic pain

The Persistent Pelvic Pain Study (PPP): Factors influencing the outcomes in women presenting with persistent pelvic pain


Sponsor

Prof Sonia Grover

Enrollment

250 participants

Start Date

Feb 9, 2015

Study Type

Observational

Conditions

Summary

AIMS: This study aims to clarify factors impacting upon outcomes in women presenting with persistent pelvic pain (PPP). The study team are keen to understand whether there are specific features of the woman, including the type and severity of the pain, the duration of these symptoms, or her response to her pain, that might influence or predict her outcome and thus potentially allow selection of the most appropriate therapeutic approach for specific patient characteristics. METHODS: Pelvic pain is the most common indication for referral to the outpatient gynaecology clinic. Information regarding this study, including study information, consent, and questionnaires regarding symptoms, quality of life(QoL), pain catastrophisation scale(PCS), will be sent to patients at the same time as their appointment information. On arrival at their first appointment, the research assistant will approach the prospective participants to ensure that initial paperwork and questionnaires were received, and offer the opportunity for questions. If the patient agrees to participate and has not completed the questionnaires they will be encouraged to do so whilst waiting. Consent to access patient data from medical records will also be sought. All clinical decisions regarding management will be independent of study questionnaires. Clinicians, who with the patient, decide that surgery for the PPP is warranted, will be asked to complete a brief survey regarding the factors influencing this decision. Follow-up questionnaires at 6 monthly intervals will be sent (either electronic, utilising survey monkey, or in paper format with reply paid envelopes, depending on patient preference). The pilot study will conclude at a minimum of 36 months. Patient questionnaires will take 15-30minutes.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria1

  • A longitudinall study including women aged 18 – 50 years with persistent pelvic pain, referred to a tertiary gynaecology hospital.

Exclusion Criteria1

  • Women are to be excluded if they are actively trying to conceive, are under investigation for infertility, have recent ultrasound evidence of a large (>4cm) complex ovarian cyst or endometrioma, or have a past history of hysterectomy.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

On presentation, participants will complete a questionnaire including 1) The Pain Catastrophizing Scale (PCS), 2) The World Health Organisation Quality of life - Bref Questionnaire, and 3) their pelvi

On presentation, participants will complete a questionnaire including 1) The Pain Catastrophizing Scale (PCS), 2) The World Health Organisation Quality of life - Bref Questionnaire, and 3) their pelvic pain levels in the last 3 months. All clinical decisions regarding management will be independent of study questionnaires. Follow-up questionnaires at 6 monthly intervals will be sent. We will recruit for 18months, and the study will conclude follow-up at a minimum of 36 months for each patient. The follow-up period is based on an attrition rate of 30% (gauged from original pilot data). Data will be analysed at each 12-month point - if clinically significant outcomes are determined, the option of gaining ethics for an extension of the follow-up period will be explored.


Locations(1)

Mercy Hospital for Women - Heidelberg

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12616000150448